The Ready and Healthy for Kindergarten Study

Rutgers The State University of New Jersey

Status: Active, not recruiting

Conditions: Parenting; Literacy; Health Behavior; Language Development

Treatments: Behavioral: Family Wellness Program (FWP)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05760573

Pro2021001575-2

R18HS028574 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

The goal of this clinical trial is to test whether a family wellness program enhances child and parenting outcomes among Latino dual language learners entering Kindergarten and their families. The main questions are: (1) To what extent does the family wellness program enhance home health and learning routines, and (2) To what extent does the family wellness program enhance child literacy, language, and social-emotional outcomes.

All participants will be asked to complete surveys and assessments.

Researchers will compare two groups: (1) Family wellness program that includes (a) 8-weekly summer sessions, (b) text messages, (c) booster sessions, and (2) usual care plus school supplies and list of resources to see if the family wellness program enhances child and parenting outcomes.

Full description

Education is a critical social determinant of health (SDOH). Latino dual language learners face large gaps in school readiness, which perpetuate inequities in academic achievement and subsequent health. Investigators developed an online family wellness program that uses anticipatory guidance on health topics intrinsically important to school readiness (e.g., nutrition, physical activity) to introduce basic language and literacy skills to Latino dual language learners, a fast- growing and particularly high-risk group, and their families. The online family wellness program was developed through a cross-sector partnership between educators and pediatric professionals and consists of parent-child workshops and reminder text messages. The program occurs during the transition into Kindergarten, a critical developmental stage, and uses promising approaches such as group structure, strategic use of technology, and partnerships. The program tightly integrates Bright Futures anticipatory guidance with the Kindergarten curriculum. During pilot testing, the investigators found that the family wellness program was feasible, well attended, and highly acceptable. The investigators now propose testing the effect of the family wellness program on child and parenting outcomes using a rigorous mixed methods and community-engaged approach. The investigators will conduct a randomized controlled trial testing the effects of the family wellness program on child language, literacy, and social-emotional outcomes as well home health and learning routines. The investigators will also conduct a mixed methods process evaluation, which will provide insight into reach and implementation as well as user experience.

Enrollment: 396 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• primary caregiver of a child entering Kindergarten (4-6 years old),
• primary caregiver identifies as Hispanic/Latino/Latinx,
• family speaks Spanish at home,
• cell phone ownership,
• willing to receive text messages,
• ability to pick up program materials locally, and
• willing to accept randomization

Exclusion criteria

-Individuals unable to provide informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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396 participants in 2 patient groups

Usual care plus school supplies and resources

No Intervention group

Description:

This group will not be enrolled in the Family Wellness Program. They will receive usual care from their regular clinician plus a backpack with schools supplies and a list of resources.

Famliy Wellness Program

Experimental group

Description:

This group will be enrolled in the Family Wellness Program which consists of 8 weekly parent-child workshops prior to the children entering kindergarten as well as 4 booster sessions during the child's kindergarten year. As part of the program families will receive school supplies, books and resources.

Treatment:

Behavioral: Family Wellness Program (FWP)